PEAK: A randomized phase II study to compare the efficacy of panitumumab plus mFOLFOX6 to bevacizumab plus mFOLFOX6 in patients (pts) with previously untreated, unresectable metastatic colorectal cancer (mCRC) expressing wild-type <i>KRAS</i>.
Bibliographic record
Abstract
TPS189 Background: Panitumumab, a high-affinity, fully human monoclonal antibody against human epidermal growth factor receptor, has demonstrated efficacy with respect to objective tumor response and progression-free survival (PFS) with an acceptable safety profile in pts with mCRC expressing wild-type KRAS when used as monotherapy and in combination with chemotherapy. This study will provide comparative data on efficacy and safety of panitumumab plus mFOLFOX6 relative to a current standard of care (bevacizumab plus mFOLFOX6) as first-line treatment in pts with mCRC tumors expressing wild-type KRAS. Methods: This phase II, open-label, randomized, multicenter study is being conducted in the US, Canada, Belgium, Germany, Spain, and Italy; 50 of 280 planned pts have enrolled. Pts ≥ 18 years with adenocarcinoma of the colon or rectum with unresectable metastatic disease expressing wild-type KRAS are eligible. Pts must have Eastern Cooperative Oncology Group (ECOG) status 0 or 1 and at least 1 unidimensionally measurable lesion. Pts may not have had prior chemotherapy or other systemic anticancer therapy for mCRC or prior adjuvant chemotherapy for the treatment of colorectal cancer ≤ 52 weeks prior to randomization, or be unable to receive panitumumab, bevacizumab, or mFOLFOX6. Fixed, paraffin-embedded primary or metastatic tumor tissue and blood samples will be collected for biomarker analyses. The primary objective is to estimate the treatment effect on PFS of panitumumab relative to bevacizumab in combination with mFOLFOX6. Secondary objectives include the evaluation of overall survival, objective response, duration of response, time to progression, time to response, resection rate, and safety. Exploratory objectives include investigation of correlations between tumor protein levels (e.g., PTEN) and tumor RNA levels (e.g., epiregulin, amphiregulin) with efficacy; effect of tumor genetic variation in signal transduction genes, cancer-associated genes, drug target genes, and other biomarker genes on efficacy (also in subsets of pts). Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Amgen Amgen Amgen Amgen
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.003 |
| Insufficient payload (model declined to judge) | 0.010 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".